MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA; SUCTION PUMP

Model Number	2208011
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As richard wolf gmbh (rw gmbh) identified a previous complaint with a similar issue that was determined to be a reportable event that involved a serious injury, we consider this case to be a reportable malfunction.
Event or Problem Description
During a holmium laser enucleation of the prostate (holep) procedure, the doctor reported that when using the piranha function, the machine kept sucking in a lot of air and resetting.Immediately upon morcellation, air started going through the lines, and the system would evacuate and restart throughout the entire procedure.The procedure was completed successfully.However, it took 20 minutes longer for the doctor to complete the procedure while trouble shooting the device.There are no reports of injuries or risks to the patient or other personnel.

• Brand Name: PIRANHA
• Common Device Name: SUCTION PUMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: anja ehrenfeuchter ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 24888670
• Report Number: 9611102-2026-00013
• Device Sequence Number: 10460279
• Product Code: JCX
• UDI-Device Identifier: 04055207011874
• UDI-Public: 04055207011874
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K041610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 2208011
• Device Catalogue Number: 2208011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART ID: 2030108 FOOTSWITCH 1 PEDAL.; PART ID: 2303.011 MOTOR CONTROL UNIT 2303.
• Patient Sex: Unknown